Meddock Raymond P, Bloemer Deirdre
J Pediatr Pharmacol Ther. 2018 Nov-Dec;23(6):473-478. doi: 10.5863/1551-6776-23.6.473.
Neonatal abstinence syndrome (NAS) is characterized by withdrawal symptoms in neonates exposed to legal or illegal substances , and it is often managed with medications such as opiates, phenobarbital, and clonidine. Clonidine use is increasing, but further safety data regarding its use in neonates are warranted. This study evaluated the effects of clonidine on heart rate and blood pressure in neonates treated for NAS at doses up to 24 mcg/kg/day.
A retrospective review via the electronic medical record of infants at least 35 weeks' gestation treated adjunctively with clonidine for NAS in the neonatal intensive care unit at St Elizabeth was conducted. Heart rate, and systolic and diastolic blood pressure were recorded at baseline, while on different dose ranges of clonidine (small: ≤1.5 mcg/kg per dose every 3 hours; medium: >1.5 to 2 mcg/kg per dose every 3 hours; and large: >2 mcg/kg to 3 mcg/kg per dose every 3 hours), and upon discontinuation.
A total of 64 infants treated with clonidine for NAS between August 2015 and December 2016 were included. Heart rate decreased in all clonidine dose ranges compared with baseline (average reduction of 7 bpm [CI: -12 to -2], 9 bpm [CI: -16 to -2], and 10 bpm [CI: -18 to -1] for the small, medium, and large dose ranges, respectively; p < 0.0001). Systolic and diastolic blood pressure were not significantly different from baseline when infants were receiving any dose of clonidine, except diastolic blood pressure while on medium-dose range clonidine, where diastolic blood pressure was higher than baseline (p = 0.0128). Increases in systolic and diastolic blood pressure were evident upon discontinuation of clonidine (p < 0.0001 and p = 0.0156, respectively).
Clonidine doses up to 24 mcg/kg/day are well tolerated in neonates ≥35 weeks' gestation treated for NAS. Any decreases in heart rate are likely clinically insignificant, and increases in blood pressure upon discontinuing clonidine are mild and may be mitigated further with extended discontinuation protocols. Further trials should be conducted to evaluate the long-term safety of clonidine in this population.
新生儿戒断综合征(NAS)的特征是接触合法或非法物质的新生儿出现戒断症状,通常使用阿片类药物、苯巴比妥和可乐定等药物进行治疗。可乐定的使用正在增加,但有必要获取更多关于其在新生儿中使用的安全性数据。本研究评估了可乐定对接受NAS治疗的新生儿心率和血压的影响,剂量最高可达24 mcg/kg/天。
通过电子病历对在圣伊丽莎白新生儿重症监护病房接受可乐定辅助治疗NAS的至少孕35周的婴儿进行回顾性研究。在基线时、使用不同剂量范围可乐定(小剂量:每3小时≤1.5 mcg/kg/剂;中等剂量:每3小时>1.5至2 mcg/kg/剂;大剂量:每3小时>2 mcg/kg至3 mcg/kg/剂)时以及停药后记录心率、收缩压和舒张压。
纳入了2015年8月至2016年12月期间接受可乐定治疗NAS的64例婴儿。与基线相比,所有可乐定剂量范围的心率均下降(小剂量、中等剂量和大剂量范围的平均下降分别为7次/分钟[CI:-12至-2]、9次/分钟[CI:-16至-2]和10次/分钟[CI:-18至-1];p<0.0001)。当婴儿接受任何剂量可乐定时,收缩压和舒张压与基线无显著差异,但在中等剂量范围可乐定时舒张压高于基线(p = 0.0128)。停药后收缩压和舒张压明显升高(分别为p<0.0001和p = 0.0156)。
对于接受NAS治疗的孕≥35周的新生儿,高达24 mcg/kg/天的可乐定剂量耐受性良好。心率的任何下降在临床上可能无显著意义,停药后血压升高轻微,延长停药方案可能会进一步减轻这种情况。应进行进一步试验以评估可乐定在该人群中的长期安全性。